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Clinical trial units for First-in-Human studies

First-in-Human study

Clinical studies of medicinal products are divided into different phases. The first phase is called Phase 1. If this is the first time a new medicinal product is given to humans, the study is called a First-in-Human study. In Sweden, there are several clinical trial units in the healthcare system that conduct First-in-Human studies. A couple of these study units are run by the regional nodes of Clinical Studies Sweden.

First-in-Human clinical trial units within the regional nodes of Clinical Studies Sweden

Other Swedish clinical trial units for First-in-Human studies

Clinical trial units for First-in-Human studies

A clinical trial unit conducting First-in-Human studies must be appropriate in terms of the design of the premises, staff competence and the internal procedures for safety monitoring and emergency care. This is usually assessed during an inspection by the Swedish Medical Products Agency. The purpose of the inspection is to ensure that:

  • the rights, safety and well-being of study participants are respected
  • the investigator and other staff have qualifications and experience in conducting early phase clinical studies of medicinal products as well as training in GCP and intensive care
  • the premises are suitable and there is access to intensive care
  • procedures are in place and measures have been taken to minimise the risks associated with First-in-Human studies.

The clinical trial units that regularly performs First-in-Human studies have undergone a system inspection and deemed suitable for conducting First-in-Human studies in accordance with applicable regulations. Regular inspections are then carried out by the Swedish Medical Products Agency.

If one single First-in-Human study is to be conducted at a clinic/site, the inspection takes place during, or in close connection with, the application for authorisation of the study from the Swedish Medical Products Agency. The inspectors assess whether the site/clinic is suitable for conducting the First-in-Human study in question in accordance with applicable regulations.

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